Patients enrolled from each center according to confirmed criteria specified in
cooperative scheme are randomly assigned to standard induction and consolidation
chemotherapy with microtransplantation (MST-group)or without (CT-group).Compare the
remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate of
the two groups.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02171117.
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte
colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells
(GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in
Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach
75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected
without GVHD. The results have been clinically validated in several other centers in
China, United States and Australia. Based on these facts, to further validate the
therapeutic efficacy, we propose a phase III clinical trial in which the de novo AML
patients ≥60 years old are randomly assigned to receive standard induction and
consolidation chemotherapy with or without microtransplantation.
Lead OrganizationThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences